Jun 16, 2022

Job Description

80 products in the pipeline, innovative concepts and technologies and a continuously increasing impact on the overall Novartis technical development portfolio! As part of our QA Medical Device Team, you will support us in actively mastering this challenge every day and thus making high-quality products available to patients all over the world.

The Quality Manager will provide quality assurance expertise, guidance and support to various operational activities in Technical Research & Development (TRD) to ensure compliance with applicable regulatory requirements, Novartis procedures and quality standards.

Your key responsibilities:
Your responsibilities include, but are not limited to:
• Lead project related activities for TRD product portfolio (e.g. development of new tools, processes, Quality initiatives, Quality Manual implementation, Quality Plans, Quality Risk Assessments, training activities)
• Provide quality and compliance expertise in the area of responsibility for medical devices and combination products.
• Support Quality integration projects
• Write, review, decide on approval and/or release of GMP-relevant deliverables and tools as per area of responsibility in order to ensure compliance with cGMP and project quality deliverables.
• Support maintenance of the regulatory required files for notified body/ health authority inspections and assist with notified body/ health authority inspection management
• Support generation of Quality Plans & review other plans for quality/safety aspects for clinical programs
• Support initiatives to maintain or improve quality performance and compliance of operational activities
• Ensure quality issues are identified and resolved consistently, in a timely and compliant manner; assist with root cause investigations; support the development of corrective and preventative action plans (CAPA), including monitoring status to ensure issues are addressed, completed and documented.
• Meet internal and external guidelines regarding quality and safety and promote and enforce compliance to such guidelines (Quality Manual, regulatory cGMP guidelines and medical device regulations, Health Authority guidance and SOPs, etc.).

Diversity & Inclusion / EEO

Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Minimum Requirements

What you’ll bring to the role:
• Bachelor’s degree with 5+ years’ experience or master’s degree with 3+ years’ experience in pharma Quality Assurance and operational areas.
• English fluent in speaking / writing, German and/or French desirable
• Good knowledge of cGMP, working knowledge in technical development or commercial manufacturing, production or analytics.
• Sound scientific, technical and regulatory knowledge.
• Strong organizational and decision-making skills, ability to work independently with little to no supervision.
• Ability to influence people, negotiate and communicate.
• Strong and shown ability to analyze and evaluate cGMP compliance and product safety. Able to navigate in a regulated environment with the flexibility given to the development phase#
• Knowledge in medical device or combination product regulations, standards and guidelines is a plus
• Experience in ophthalmology devices and in Software as Medical Devices

*Some restrictions on flexible working options may apply and will be discussed during interview, if applicable

Why Novartis?

766 million lives were touched by Novartis medicines in 2020, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives. We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working. We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying!

Imagine what you could do here at Novartis!
Global Drug Development
Full Time
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Quality Manager Medical Device (*80-100%)

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